Clinical Development

Tailored strategies to support accelerated time to market

  • development and utilization of a well defined target label
  • state of the art designs and robust criteria for milestone decisions to ensure cost-effectiveness
  • active management to secure data integrity and data integration from different sources to allow the most rapid production of clinical summaries for marketing applications
  • management of CRO selection and provision of oversight 

Key Deliverables

Our multi-disciplinary team of senior consultants

  • generates and reviews clinical development plans
  • integrates risk minimization measures into pivotal studies
  • advises on clinical and operational performance indicators
  • develops competitive service specifications and budget models
  • provides medical monitoring and safety management
  • contributes to data monitoring committees and strategy advisory boards
  • supports marketing authorization applications and interactions with regulatory agencies
    in the pre-, peri- and post-approval phases